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Re Engineering Clinical Trials

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Re Engineering Clinical Trials

Re Engineering Clinical Trials Book
Author : Peter Schüler
Publisher : Academic Press
Release : 2015-01-02
ISBN : 9780124202467
Language : En, Es, Fr & De

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Book Description :

The pharmaceutical industry is currently operating under a business model that is not sustainable for the future. Given the high costs associated with drug development, there is a vital need to reform this process in order to provide safe and effective drugs while still securing a profit. Re-Engineering Clinical Trials evaluates the trends and challenges associated with the current drug development process and presents solutions that integrate the use of modern communication technologies, innovations and novel enrichment designs. This book focuses on the need to simplify drug development and offers you well-established methodologies and best practices based on real-world experiences from expert authors across industry and academia. Written for all those involved in clinical research, development and clinical trial design, this book provides a unique and valuable resource for streamlining the process, containing costs and increasing drug safety and effectiveness. Highlights the latest paradigm-shifts and innovation advances in clinical research Offers easy-to-find best practice sections, lists of current literature and resources for further reading and useful solutions to day-to-day problems in current drug development Discusses important topics such as safety profiling, data mining, site monitoring, change management, increasing development costs, key performance indicators and much more

Re Engineering Clinical Trials

Re Engineering Clinical Trials Book
Author : Peter Schueler,Brendan Buckley
Publisher : Academic Press
Release : 2014-12-16
ISBN : 0128007907
Language : En, Es, Fr & De

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Book Description :

The pharmaceutical industry is currently operating under a business model that is not sustainable for the future. Given the high costs associated with drug development, there is a vital need to reform this process in order to provide safe and effective drugs while still securing a profit. Re-Engineering Clinical Trials evaluates the trends and challenges associated with the current drug development process and presents solutions that integrate the use of modern communication technologies, innovations and novel enrichment designs. This book focuses on the need to simplify drug development and offers you well-established methodologies and best practices based on real-world experiences from expert authors across industry and academia. Written for all those involved in clinical research, development and clinical trial design, this book provides a unique and valuable resource for streamlining the process, containing costs and increasing drug safety and effectiveness. Highlights the latest paradigm-shifts and innovation advances in clinical research Offers easy-to-find best practice sections, lists of current literature and resources for further reading and useful solutions to day-to-day problems in current drug development Discusses important topics such as safety profiling, data mining, site monitoring, change management, increasing development costs, key performance indicators and much more

Clinical Trials

Clinical Trials Book
Author : Tom Brody
Publisher : Academic Press
Release : 2016-02-19
ISBN : 0128042583
Language : En, Es, Fr & De

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Book Description :

Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more Extensively covers the "study schema" and related features of study design Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers

A Comprehensive and Practical Guide to Clinical Trials

A Comprehensive and Practical Guide to Clinical Trials Book
Author : Delva Shamley,Brenda Wright
Publisher : Academic Press
Release : 2017-06-07
ISBN : 0128047305
Language : En, Es, Fr & De

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Book Description :

A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end. Describes the entire clinical trial management process from start to finish in a step-by-step guide Provides best practice elements, including case studies, practical examples, activities, and checklists Accompanied by a website with PowerPoint slides and an image bank

Oncology Clinical Trials

Oncology Clinical Trials Book
Author : William Kevin Kelly, DO,Susan Halabi, PhD
Publisher : Springer Publishing Company
Release : 2018-03-28
ISBN : 0826168736
Language : En, Es, Fr & De

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Book Description :

The second edition of Oncology Clinical Trials has been thoroughly revised and updated and now contains the latest designs and methods of conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents—including trials investigating the safety and efficacy of targeted therapies, immunotherapies, and combination therapies as well as novel radiation therapy modalities. Now divided into six sections this revamped book provides the necessary background and expert guidance from the principles governing oncology clinical trials to the innovative statistical design methods permeating the field; from conducting trials in a safe and effective manner, analyzing and interpreting the data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials. Considered by many as the gold standard reference on oncology clinical trials in the field, the second edition continues to provide examples of real-life flaws and real-world examples for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology. NEW TO THIS EDITION: Outlines how to design clinical trials with and without biomarker testing—including genomics-based “basket” trials, and adaptive trials for all phases during treatment and quality-of-life trials Includes new chapters on immunotherapy trials, radiation therapy trials, multi-arm trials, meta-analysis and adaptive design, use of genomics, dose modifications and use of ancillary treatments in investigational studies, establishing surrogate endpoints, practical issues with correlative studies, cost-effectiveness analysis, and more Comprehensively covers all regulatory aspects in the pursuit of global oncology trials Digital access to the ebook included

Innovation in Clinical Trial Methodologies

Innovation in Clinical Trial Methodologies Book
Author : Peter Schueler
Publisher : Academic Press
Release : 2020-11-01
ISBN : 0323860060
Language : En, Es, Fr & De

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Book Description :

Innovation in Clinical Trial Methodologies: Lessons Learned during the Corona Pandemic presents a selection of updated chapters from Re-Engineering Clinical Trials that feature innovative options and methods in clinical trials. The Coronavirus pandemic is an accelerator for digitalization in many industries, including clinical trials. This book considers best practices, alternative study concepts requiring fewer patients, studies with less patient interaction, the design of "virtualized" protocols, and moving from data to decisions. This book will be helpful to pharmacologists, physicians and clinical researchers involved in the process of clinical development and clinical trial design. Considers multiple digital and virtual strategies Explores best practices, including the use of reduced patient involvement Brings together expert, trusted information to increase the efficiency and effectiveness of clinical trials

Applications of Evolutionary Computation

Applications of Evolutionary Computation Book
Author : Giovanni Squillero,Paolo Burelli
Publisher : Springer
Release : 2016-03-22
ISBN : 3319312049
Language : En, Es, Fr & De

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Book Description :

The two volumes LNCS 9597 and 9598 constitute the refereed conference proceedings of the 19th European Conference on the Applications of Evolutionary Computation, EvoApplications 2016, held in Porto, Portugal, in March/April 2016, co-located with the Evo* 2016 events EuroGP, EvoCOP, and EvoMUSART. The 57 revised full papers presented together with 17 poster papers were carefully reviewed and selected from 115 submissions. EvoApplications 2016 consisted of the following 13 tracks: EvoBAFIN (natural computing methods in business analytics and finance), EvoBIO (evolutionary computation, machine learning and data mining in computational biology), EvoCOMNET (nature-inspired techniques for telecommunication networks and other parallel and distributed systems), EvoCOMPLEX (evolutionary algorithms and complex systems), EvoENERGY (evolutionary computation in energy applications), EvoGAMES (bio-inspired algorithms in games), EvoIASP (evolutionary computation in image analysis, signal processing, and pattern recognition), EvoINDUSTRY (nature-inspired techniques in industrial settings), EvoNUM (bio-inspired algorithms for continuous parameter optimization), EvoPAR (parallel implementation of evolutionary algorithms), EvoRISK (computational intelligence for risk management, security and defence applications), EvoROBOT (evolutionary robotics), and EvoSTOC (evolutionary algorithms in stochastic and dynamic environments).

Departments of Labor and Health and Human Services Education and Related Agencies Appropriations

Departments of Labor  and Health and Human Services  Education  and Related Agencies Appropriations Book
Author : United States. Congress. Senate. Committee on Appropriations
Publisher : Unknown
Release : 2007
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Departments of Labor and Health and Human Services Education and Related Agencies Appropriations book written by United States. Congress. Senate. Committee on Appropriations, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Departments of Labor Health and Human Services Education and Related Agencies Appropriations for 2007

Departments of Labor  Health and Human Services  Education  and Related Agencies Appropriations for 2007 Book
Author : United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies
Publisher : Unknown
Release : 2006
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Departments of Labor Health and Human Services Education and Related Agencies Appropriations for 2007 book written by United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

From Clinical Trials to Community

From Clinical Trials to Community Book
Author : Anonim
Publisher : Unknown
Release : 2004
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download From Clinical Trials to Community book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Re Engineering of the Damaged Brain and Spinal Cord

Re Engineering of the Damaged Brain and Spinal Cord Book
Author : Klaus R.H. Wild
Publisher : Springer Science & Business Media
Release : 2007-08-09
ISBN : 3211275770
Language : En, Es, Fr & De

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Book Description :

Traumatic Brain Injury (TBI) can lead to loss of skills and to mental cognitive behavioural deficits. Paraplegia after Spinal Cord Injury (SCI) means a life-long sentence of paralysis, sensory loss, dependence and in both, TBI and SCI, waiting for a miracle therapy. Recent advances in functional neurosurgery, neuroprosthesis, robotic devices and cell transplantation have opened up a new era. New drugs and reconstructive surgical concepts are on the horizon. Social reintegration is based on holistic rehabilitation. Psychological treatment can alleviate and strengthen affected life. This book reflects important aspects of physiology and new trans-disciplinary approaches for acute treatment and rehabilitation in neurotraumatology by reviewing evidence based concepts as they were discussed among bio and gene-technologists, physicians, neuropsychologists and other therapists at the joint international congress in Brescia 2004.

Revitalizing New Product Development from Clinical Trials Through FDA Review

Revitalizing New Product Development from Clinical Trials Through FDA Review Book
Author : United States,United States. Congress. Senate. Committee on Labor and Human Resources
Publisher : Unknown
Release : 1996
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Revitalizing New Product Development from Clinical Trials Through FDA Review book written by United States,United States. Congress. Senate. Committee on Labor and Human Resources, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Top Research in Podiatry Education An Issue of Clinics in Podiatric Medicine and Surgery E Book

Top Research in Podiatry Education  An Issue of Clinics in Podiatric Medicine and Surgery  E Book Book
Author : Thomas Chang
Publisher : Elsevier Health Sciences
Release : 2020-03-07
ISBN : 0323733824
Language : En, Es, Fr & De

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Book Description :

This issue of Clinics in Podiatric Medicine and Surgery will take a unique look at some of the top research currently underway across many of the top schools of Podiatric Medicine and Surgery in the United States. The issue will be edited by our series Consulting Editor, Dr. Thomas Chang, and will feature review articles from physicians at the following 9 Institutions: Des Moines University College of Podiatric Medicine and Surgery; Arizona School of Podiatric Medicine; Temple University School of Podiatric Medicine; Samuel Merritt – California School of Podiatric Medicine; Kent State University College of Podiatric Medicine; New York College of Podiatric Medicine; Dr. William M. Scholl College of Podiatric Medicine; Barry University School of Podiatric Medicine; Western University College of Podiatric Medicine. Topics covered in the issue include: Mechanics of the Jones Fracture; 3D Printing for Foot and Ankle Surgical Planning and Research; Orthoplastic Approach for Diabetic Foot Salvage; Multi drug resistant organisms with new technology; Motion Analysis is being used to advance podiatric biomechanics; Gene Expression in post op pain and Charcot; Primary Deltoid Repair in Rotational Ankle Injuries; The Impact of Vitamin D Levels in Foot and Ankle Surgery; Plantar Verrucae in HIV Infection; The role of the podiatrist in assessing and reducing fall risk; Offloading for the Diabetic Foot - Considerations and Implications; Efinicanazole use in the diabetic population study; The use of Virtual Reality in Podiatric Education; among others.

Departments of Labor Health and Human Services Education and Related Agencies Appropriations for 2000

Departments of Labor  Health and Human Services  Education  and Related Agencies Appropriations for 2000 Book
Author : United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies
Publisher : Unknown
Release : 1999
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Departments of Labor Health and Human Services Education and Related Agencies Appropriations for 2000 book written by United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Departments of Labor Health and Human Services Education and Related Agencies Appropriations for 2001

Departments of Labor  Health and Human Services  Education  and Related Agencies Appropriations for 2001 Book
Author : United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies
Publisher : Unknown
Release : 2000
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Departments of Labor Health and Human Services Education and Related Agencies Appropriations for 2001 book written by United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Assessing Quality of Life in Clinical Trials

Assessing Quality of Life in Clinical Trials Book
Author : Peter M. Fayers,Ron Hays,Ron D. Hays
Publisher : Oxford University Press, USA
Release : 2005
ISBN : 9780198527695
Language : En, Es, Fr & De

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Book Description :

Researchers in all clinical fields are fully aware of the importance of Quality of Life measurements in judging the efficacy of a given treatment. Psychological criteria play an important role in this evaluation. This volulme explores the current state of the art and illustrates the benefits and potential of health related quality of life assessment in clinical trials. It covers a wide range of analytical issues, emphasizing new and innovative approaches that are of practical and clinical importance.

Departments of Labor Health and Human Services and Education and related agencies appropriation bill 2006 report together with minority views to accompany H R 3010

Departments of Labor  Health and Human Services  and Education  and related agencies appropriation bill  2006   report together with minority views  to accompany H R  3010   Book
Author : Anonim
Publisher : DIANE Publishing
Release : 2021-07-29
ISBN : 1428925325
Language : En, Es, Fr & De

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Book Description :

Download Departments of Labor Health and Human Services and Education and related agencies appropriation bill 2006 report together with minority views to accompany H R 3010 book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

The Biomedical Engineering Handbook

The Biomedical Engineering Handbook Book
Author : Joseph D. Bronzino,Donald R. Peterson
Publisher : CRC Press
Release : 2018-10-03
ISBN : 1439863113
Language : En, Es, Fr & De

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Book Description :

The definitive "bible" for the field of biomedical engineering, this collection of volumes is a major reference for all practicing biomedical engineers and students. Now in its fourth edition, this work presents a substantial revision, with all sections updated to offer the latest research findings. New sections address drugs and devices, personali

FDA s Drug Review Process and the Package Label

FDA s Drug Review Process and the Package Label Book
Author : Tom Brody
Publisher : Academic Press
Release : 2017-12-13
ISBN : 0128146486
Language : En, Es, Fr & De

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Book Description :

FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label. Reveals strategies for winning FDA approval and for drafting the package label Examples are from one hundred FDA-submissions (NDAs, BLAs) for one hundred different drugs, e.g., for oncology, metabolic diseases, autoimmune diseases, and neurological diseases This book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely, the data from NDAs and BLAs as published on FDA's website at the time FDA grants approval to the drug

Modern Approaches to Clinical Trials Using SAS Classical Adaptive and Bayesian Methods

Modern Approaches to Clinical Trials Using SAS  Classical  Adaptive  and Bayesian Methods Book
Author : Sandeep Menon,Richard C. Zink
Publisher : SAS Institute
Release : 2015-12-09
ISBN : 1629600849
Language : En, Es, Fr & De

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Book Description :

This book covers domains of modern clinical trial design: classical, group sequential, adaptive, and Bayesian methods applicable to and used in various phases of pharmaceutical development. Written for biostatisticians, pharmacometricians, clinical developers, and statistical programmers involved in the design, analysis, and interpretation of clinical trials, as well as students in graduate and postgraduate programs in statistics or biostatistics, it covers topics including: dose-response and dose-escalation designs; sequential methods to stop trials early for overwhelming efficacy, safety, or futility; Bayesian designs incorporating historical data; adaptive sample size re-estimation and randomization to allocate subjects to effective treatments; population enrichment designs. Methods are illustrated using clinical trials from diverse therapeutic areas, including dermatology, endocrinology, infectious disease, neurology, oncology and rheumatology. --